Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT04477902
Status:
COMPLETED
Last Update Posted:
2021-06-24
First Post:
2020-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Experience and Health Effects of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-22', 'studyFirstSubmitDate': '2020-07-16', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Longitudinal survey', 'timeFrame': '2 years', 'description': 'To gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19', 'corona virus', 'covid19', 'coronavirus', 'SARS-CoV-2', 'infection', 'household', 'transmission', 'vaccine', 'clinical trials', 'online', 'Altura', 'outpatient', 'telemedicine'], 'conditions': ['Covid19', 'Corona Virus Infection', 'Quality of Life', 'Risk Reduction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. Data will be deidentified and consolidated to create a large national longitudinal database.', 'detailedDescription': 'Ths is a longitudinal, observational, descriptive study to gather data needed to support a better understanding of COVID-19 from the perspective of a diverse national population.\n\nThis multi-phase study will use an action research approach to identify specific ways that physician groups, federally qualified health centers (FQHCs), public health departments, and other health and social services systems in the United States can address healthcare needs and mitigate the transmission of COVID-19. Email surveys will be used to assess the historical and current status of participants by medical condition, geography, and demographic characteristics, as well as their history of symptoms (e.g. recent cough, fever, loss of sense of taste or smell, etc.) and their current psychosocial needs.\n\nThe study will provide the structure for an iterative exploration of trends over time (up to 24 months). The opt-in survey will be posted and available to individuals 18 and older who choose to participate. Survey frequency will be every two weeks.\n\nTo analyze broader trends, all survey responses will be de-identified and aggregated. Overall general findings will not be linked to individuals or physician groups when reporting and publishing study results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Anyone in the USA can participate in this study that meets inclusion criteria. To ensure diversity urban, suburban and rural areas of the country will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Any gender specification\n* Has consented to proceed with survey\n* Is able to complete the survey via email on a regular basis\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04477902', 'briefTitle': 'Long-Term Experience and Health Effects of COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Altura'}, 'officialTitle': 'A Longitudinal, Long-Term, Observational Study of COVID-19 Experience and Health Effects', 'orgStudyIdInfo': {'id': 'altcovid-192020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'none - observational', 'type': 'OTHER', 'description': 'online survey'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Altura', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}], 'overallOfficials': [{'name': 'Pete Fronte, MBA', 'role': 'STUDY_CHAIR', 'affiliation': 'Altura'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Altura', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}